BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3760874 · Received April 4, 2014

    Report

    Report Number
    3003288808-2014-00613
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 12, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED TRANSIENT LIGHT SENSITIVITY 2 MONTHS AFTER BILATERAL LASIK. PATIENT WAS PLACED ON A STEROID DROP. MULTIPLE ATTEMPTS HAVE BEEN MADE BY THE FACILITY TO GET PATIENT IN TO BE CHECKED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT REFERENCES THE RIGHT EYE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFORMATION, AT THIS TIME ADD'L INFO HAS NOT BEEN REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203738 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention INTRALASE